New FDA Fees for Drug Master Files published

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The US FDA has published the new fees for 2014. In a Federal Register Statement dated August 2, 2013 the following information has been published:

Under the Generic Drug User Fee Act (GDUFA), the Drug Master File (DMF) fee is owed by each person that owns a type II active pharmaceutical ingredient DMF that is referenced, on or after October 1, 2012, in a generic drug submission by an initial letter of authorization. This is a one-time fee for each individual DMF. This fee is due no later than the date on which the first generic drug submission is submitted that references the associated DMF. If a DMF has successfully undergone an initial completeness assessment and the fee is paid, the DMF will be placed on a publicly available list documenting DMFs available for reference. Thus, some DMF holders may choose to pay the fee prior to the date that it would otherwise be due in order to have the DMF placed on that list. For Fiscal Year 2014 the fee is $31.460.

In addition to the Drug Master File fee an API facility fee has to be paid. The calculation is based on the number of API facilities. According to the current FDA calculation there are 128 domestic facilities (based in the US) and 775 foreign facilities (outside the US) producing APIs used for Generic Drugs in the US. The domestic API facility fee is $34,515. The foreign API facility fee is $15.000 more than the domestic API facility fee, in total $49.515.

Source: Federal Register, August 2, 2013